Biovigilance responsibilities of sponsors of biologicals

Australian requirements and recommendations

This guidance is for all sponsors of products regulated as biologicals.

Published

1 December 2017

Note

This Guidance is directly referenced in legislation and must be presented in its original publication format.

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1 December 2017

Version 1.0: Original publication following public consultation on guidance in October 2016.

1 December 2017

Version 1.0: Original publication following public consultation on guidance in October 2016.